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Evaluation of Hormonal Contraceptive Treatments in Obese Women (OBECO)

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ClinicalTrials.gov Identifier: NCT02398903
Recruitment Status : Unknown
Verified October 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : March 26, 2015
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The aim of our study is to assess the concentrations of different oral contraceptive agents in morbid obese women before and after two types of bariatric surgeries (RYGB and sleeve gastrectomy) in order to study the role of the surgery and the role of body weight on drug concentrations, and to compare these concentrations with those of normal-weight women.

Condition or disease Intervention/treatment
Obesity Bariatric Surgery Candidate Oral Contraceptive Other: Blood samples for measurement of drug Css Other: DXA and impedancemetry

Detailed Description:

Open, multi-center pharmacological study of residual concentrations of three different oral contraceptives in 3 groups of obese women in each group of surgery, and 1 group of healthy volunteers. The concentrations will be assessed before, 6 and 12 months after bariatric surgery restrictive (sleeve gastrectomy) or malabsorptive (gastric by pass).

Contraception is an important issue in women with obesity. There are actually few data answering the questions of the efficacy of oral contraceptive in obese women, as this condition could be a risk factor for failure of hormonal contraception, due to the changes in drug metabolism and a larger volume of distribution in obesity. Bariatric surgery is the most efficient therapeutic for weight loss in severe and morbid obesity. In 2011, more than 31 000 bariatric procedures have been performed in France with sleeve gastrectomy and Roux-en-Y gastric bypass (RYGB) representing the two most frequent procedures. Women represent 80 % of surgical patients and most of them are in childbearing age (mean age of 39 years). Obese women who receive surgical treatment for obesity are advised not to conceive for the following 12 to 18 months, both to ensure optimal weight loss and a stable weight during pregnancy, and also to begin pregnancy with optimal nutritional and vitamin status. There are no data on the changes in oral contraceptives concentrations before and after bariatric surgery, as malabsorption and anatomic digestive modifications following surgery may theoretically affect bioavailability.

Primary Objective :

The difference between Css before bariatric surgery and 6 months after the surgery in obese women regardless of the oral contraceptives used. Three different oral contraceptives are employed (two combined oral contraceptive containing ethinyl E2 and levonorgestrel and a progestin contraceptive desogestrel).

Secondary Objectives :

  • To assess if the difference of Css before, 6 months and 12 months after surgery is the same in the 3 groups of oral contraceptives and in the 2 groups of surgery
  • To compare the Css of obese women before, 6 months and 12 months after surgery to T0 Css of normal-weight patients for each group of oral contraceptive
  • To assess the impact of oral contraceptives on gonadotroph axis, hemostatic variables and estrogen-sensitive protein in obese women before and 6 and 12 months after surgery and in normal-weight women
  • Analyze of correlation between body composition, nutritional status and Css in the 3 groups of oral contraceptives and in the 2 groups of bariatric surgery

Secondary End Points:

  • Css of oral contraceptive agent 12 months after bariatric surgery
  • Css of oral contraceptive agent in normal weight women
  • Sequential Body composition by DXA and Impedancemetry before and 6 months and 12 months after surgery.
  • Nutritional status in obese women before and after surgery (albumin, prealbuminemia, RBP, transferrin, haemoglobin, lipid (total cholesterol, triglycerides, LDL and HDL)
  • Evaluation of gonadotroph axis by hormonal assays: FSH, LH, estradiol, AMH, progesterone, testosterone total, Inhibin B in normal-weight women and obese women before and 6 months and 12 months after surgery
  • Evaluation of hemostatic variables (protein S, APC) and SHBG in normal-weight women and obese women before and 6 months and 12 months after surgery
  • Number of unexpected pregnancies occurred during the study

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Study Type : Observational
Estimated Enrollment : 174 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacological Evaluation of Hormonal Contraceptive Treatments in Obese Women Before and After Bariatric Surgery
Actual Study Start Date : March 16, 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Obese women SG
Obese women operated by sleeve gastrectomy
Other: Blood samples for measurement of drug Css
Blood samples for measurement of drug Css

Other: DXA and impedancemetry
Body composition by DXA and impedancemetry

Normal weight women
Normal weight women
Other: Blood samples for measurement of drug Css
Blood samples for measurement of drug Css

Other: DXA and impedancemetry
Body composition by DXA and impedancemetry

Obese women GBP
Obese women operated by Rougastric bypass
Other: Blood samples for measurement of drug Css
Blood samples for measurement of drug Css

Other: DXA and impedancemetry
Body composition by DXA and impedancemetry




Primary Outcome Measures :
  1. Css [ Time Frame: 6 months ]
    The difference between Css before bariatric surgery and 6 months after the surgery in obese women regardless of the oral contraceptives used. Three different oral contraceptives are employed (two combined oral contraceptive containing ethynil E2 and levonorgestrel and a progestin contraceptive desogestrel).


Secondary Outcome Measures :
  1. Css [ Time Frame: 12 months ]
    • To assess if the difference of Css before, 6 months and 12 months after surgery is the same in the 3 groups of oral contraceptives and in the 2 groups of surgery


Biospecimen Retention:   Samples Without DNA
Blood samples for measurement of drug Css


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Obese women with an indication of bariatric surgery by RYGB or sleeve gastrectomy under oral contraceptive treatment.

Normal-weight women under oral contraceptive treatment.

Criteria

Eligibility Criteria:

Inclusion criteria :

  • Obese women

    • Obese women (BMI ≥ 35 kg/m² with obesity related comorbidity or BMI ≥ 40 kg/m²) with an indication of bariatric surgery by RYGB or sleeve gastrectomy under oral contraceptive treatment of interest in our study
    • Aged 18 to 45 years if desogestrel or 18 to 35 years if COC
    • Signed informed consent
    • Affiliated to The French Social Security Health insurance
  • Healthy Volunteers

    • Normal weight (BMI < 25 kg/m²)
    • Women under oral contraceptive treatment
    • Aged 18 to 45 years
    • Signed informed consent
    • Affiliated to The French Social Security Health insurance

Exclusion criteria :

  • Drug treatment known to interact with cytochrome P450 (CYP3A4).
  • Contraindication for an oral contraceptive agent as mentioned in the summary of product characteristics
  • Positive pregnancy test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02398903


Contacts
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Contact: Anne Bachelot, MD, PhD +33 1 42 16 02 46 anne.bachelot@psl.aphp.fr

Locations
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France
Hôpital Ambroise Paré Recruiting
Boulogne-Billancourt, France
Pitié Salpetriere Hospital Recruiting
Paris, France, 75013
Contact: Anne Bachelot, MD, PhD       anne.bachelot@psl.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Anne Bachelot, MD, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02398903    
Other Study ID Numbers: P 130942
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Morbid obesity
bariatric surgery
sleeve gastrectomy
Roux-en-Y gastric bypass
hormonal contraception
combined oral contraceptive
progestin contraceptive desogestrel
pharmacokinetics
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight